FDA's Failure to Act on Serzone is Illegal - Public Citizen

[Guest guest]

March 15, 2004

FDA's Failure to Act on Serzone is Illegal

Deaths and Injuries from Liver Toxicity Mount as Agency Tarries, Public

Citizen Says in Lawsuit

WASHINGTON, D.C. - Public Citizen today sued the U.S. Food and Drug

Administration (FDA) over its failure to act on a petition Public

Citizen filed more than a year ago seeking a ban of the antidepressant

drug nefazodone. The drug is marketed by Bristol-Myers Squibb as Serzone

and has been linked to a mounting number of deaths and serious injuries

from liver failure.

Public Citizen's suit, filed today in the U.S. District Court for the

District of Columbia, asks the court to find the FDA's delay illegal and

to require the agency to act. Serzone's liver toxicity is a danger to

public health, and the FDA's slow decision process continues to put

patients at risk of death or serious injury, the lawsuit says.

In March 2003, Public Citizen sought a ban on Serzone, citing 21 cases

of liver failure and 11 deaths between 1994, when nefazodone was first

marketed, and the spring of 2002. A supplemental petition, submitted to

the FDA in October 2003, included an analysis of the FDA Adverse Event

Reports Database. That analysis showed that, from April 1, 2002, through

May 12, 2003, there were 33 additional reports of liver failure -

including nine deaths - for a total of 55 patients with liver failure,

including 20 deaths.

The liver toxicity dangers of nefazodone are compounded by the fact that

it inhibits a key enzyme that is involved in the metabolism of about

half of all prescribed drugs including itself, so nefazodone increases

the toxicity dangers of other drugs a patient may be taking. Also, by

inhibiting this enzyme, nefazodone can increase its own concentration,

with potentially toxic results. Serzone has not been shown to be more

effective in controlling depression than other drugs in its class, but

it is uniquely and unpredictably toxic.

" It is grossly negligent for the FDA to allow doctors to continue to

prescribe and patients to continue to take Serzone, " said Sidney Wolfe,

M.D., director of Public Citizen's Health Research Group. " It's a shame

that we must sue to force the agency to fulfill its obligation to

protect public health. "

Nefazodone has already been removed from the market in Canada and Europe

and is scheduled to be taken off the market in Australia and New Zealand

in May. Since January 2002, a " black box " warning has been included in

its U.S. packing insert, warning of life-threatening liver damage and

recommending that physicians advise patients to be aware of signs of

liver problems. This strategy has clearly failed to curb the subsequent

cases of liver failure and death caused by the drug, Public Citizen's

lawsuit said.

" The FDA has a legal responsibility to protect the public from unsafe

drugs, and it is shirking that duty, " said Kirkpatrick, an

attorney with Public Citizen and the brief's author. " Nefazodone is a

danger and should be withdrawn now. "

During the past 30 years, Public Citizen has successfully petitioned for

bans of 15 drugs and biologic agents, including Rezulin (for diabetes),

Redux (for weight loss) and the dietary supplement ephedra.

http://www.citizen.org/pressroom/release.cfm?ID=1665

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org